Nippon Kayaku announces New Product Launch: IBTROZIⓇCapsules 200mg
2025/11/12Nippon Kayaku Co., Ltd. (Headquarters: Tokyo, Japan; President: Shigeyuki Kawamura; hereinafter "Nippon Kayaku") announces that the oncology medicine “IBTROZIⓇ Capsules 200mg(generic name: taletrectinib adipate; hereinafter, IBTROZIⓇ)”, which was in-licensed from Nuvation Bio Inc. (Headquarters: New York, The U.S.; Representative and CEO: David Hung, M.D.; hereinafter, Nuvation Bio), was listed today on the National Health Insurance (NHI) drug price list and has been launched.
Under a license agreement with Nuvation Bio, Nippon Kayaku will market the product on an exclusive basis.
Nippon Kayaku will promote the proper use of IBTROZI® for the approved indication of “ROS1 fusion gene positive unresectable, advanced and/or recurrent NSCLC” and will strive to provide scientific and medical information under applicable regulations and guidelines and ensure a stable supply, so as to further contribute to patients, their families, and healthcare professionals.
Summary of the product]
| Trade Name | IBTROZIⓇ Capsules 200mg |
|---|---|
| Generic Name | Taletrectinib adipate |
| Indication | ROS1 fusion gene positive unresectable, advanced and/or recurrent NSCLC |
| Dosage and Administration | The usual dosage for adults is 600 mg of taletrectinib administered orally once daily on an empty stomach. The dosage may be reduced according to the patient's condition. |
| NHI Drug Price | 9,711.20 JPY (200mg 1 capsule) |
| Date of obtaining manufacturing and marketing approval | September 19th, 2025 |
| Date of NHI price listing | November 12th, 2025 |
| Date of Launch | November 12th, 2025 |
| Manufacturing Authorization Holder | Nippon Kayaku Co., Ltd. |
Reference information
Outline of Nuvation Bio Inc.
(1) Name: Nuvation Bio Inc.
(2) Headquarters: 1500 Broadway, Suite 1401, New York, NY 10036
(3) Representative and CEO: David Hung, M.D.
(4) Established: 2018
(5) Fiscal Year End: December 31
(6) Main Business: Biotechnology
(7) Number of employees (including affiliates): 291 as of September 30, 2025
(8) Past relationship with Nippon Kayaku: Capital, personal and business relationships have not previously occurred.
About Nuvation Bio
Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients’ lives. Nuvation Bio’s diverse pipeline includes taletrectinib (IBTROZI™), a next-generation ROS1 inhibitor; safusidenib*, a brain-penetrant IDH1 inhibitor; NUV-1511*, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868*, a BD2-selective BET inhibitor.
Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai.
(https://nuvationbio.com) (*: Not approved in Japan)
About ROS1-positive NSCLC
Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1-positive disease 1. About 35% of patients newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to their brain 2. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases 2,3.
1. Journal of Clinical Oncology. 2012 Mar 10; 30 (8):863-870.
2. Journal of Thoracic Oncology. 2018 Nov; 13 (11):1717–1726
3. Lung Cancer. 2019 Apr: 130:201-207.
About IBTROZIⓇ Capsules 200mg
IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC cancer in the United States, China, and Japan. For U.S. prescribing information, please visit IBTROZI.com.
As for the detailed data presented at past scientific conferences, please visit Nuvation Bio’s website.
Contact
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TEL: +81-3-6731-5237
